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Safety and Tolerability Study of the Taris Placebo System

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ClinicalTrials.gov Identifier: NCT01051336
Recruitment Status : Completed
First Posted : January 18, 2010
Last Update Posted : January 18, 2010
Sponsor:
Information provided by:
TARIS Biomedical, Inc.

Brief Summary:
The aim of this protocol is to evaluate the tolerability of the Taris placebo system for the development program and to provide key safety and tolerability data for the Taris platform.

Condition or disease Intervention/treatment Phase
Healthy Device: TARIS Placebo Procedure: Sham Procedure Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Phase I Safety and Tolerability Study of the Taris Placebo System (A Novel Bladder Drug Delivery Platform)
Study Start Date : October 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Arm Intervention/treatment
Experimental: TARIS Placebo Device: TARIS Placebo
Sham Comparator: Sham Procedure Procedure: Sham Procedure



Primary Outcome Measures :
  1. Safety, tolerability and retention of the TARIS placebo system upon insertion, 14-day exposure and removal [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Subject reported symptoms [ Time Frame: 14 days ]
  2. Routine and microscopic urinalysis [ Time Frame: 14 days ]
  3. Urine culture [ Time Frame: 14 days ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy female volunteers, 18 to 55 years of age
  • Body weight >100 lbs and BMI (body mass index) within the range 18-30 kg/m2
  • A score of less than 11 on the pelvic pain/urgency-frequency scale (PUF)

Exclusion Criteria:

  • Presence of any bladder or urethra anatomical feature that, in the opinion of the investigator, might prevent the safe placement, indwelling use, or removal of the TARIS placebo system
  • History of significant urogenital surgery (any type of bladder suspension, prolapse repair, incontinence procedure, or vaginal hysterectomy)
  • History of kidney stone formation
  • Chronic or recurring bacterial or viral infections of the urogenital system

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01051336


Locations
United States, Arizona
Phoenix, Arizona, United States
Sponsors and Collaborators
TARIS Biomedical, Inc.
Investigators
Principal Investigator: Pankaj M Jain, M.D., M.B.A. Dedicated Phase I (Arizona Urology)

Responsible Party: Julie Himes, M.D. / Chief Medical Officer, TARIS Biomedical
ClinicalTrials.gov Identifier: NCT01051336     History of Changes
Other Study ID Numbers: TAR-100-101
First Posted: January 18, 2010    Key Record Dates
Last Update Posted: January 18, 2010
Last Verified: January 2010

Keywords provided by TARIS Biomedical, Inc.:
TARIS Placebo
Bladder
Interstitial Cystitis
Normal Healthy Volunteers